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Date:05/11/2005
Session:109th Congress (First Session)
Witness(es):Harvey V. Fineberg
Credentials:  President, Institute of Medicine, The National Academies
Chamber:Senate
Committee:Bioterrorism and Public Health Subcommittee, Committee on Health, Education, Labor, and Pensions, U.S. Senate
Subject:21st Century Biological Threats

DUAL-PURPOSE PREPAREDNESS
AGAINST NATURAL AND DELIBERATE MICROBIAL THREATS

Statement of

Harvey V. Fineberg, M.D., Ph.D.
President
Institute of Medicine
The National Academies

before the

Subcommittee on Bioterrorism and Public Health
Committee on Health, Education, Labor, and Pensions
U.S. Senate

on

May 11, 2005

Mr. Chairman, and Members of the Committee:

I speak to you today as president of the Institute of Medicine of the National Academies. (The National Academies are a congressionally chartered, independent adviser to the nation on matters of science, technology, and health. The National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the National Research Council comprise the National Academies.) Before taking up my current position in July, 2002, I served as provost of Harvard University for four years, following thirteen years as dean of the Harvard School of Public Health. Earlier, with the late professor Richard E. Neustadt, I co-authored a report on lessons learned from the ill-fated swine-flu immunization program of 1976 (R.E. Neustadt and H.V. Fineberg. The Swine Flu Affair: Decision-Making on a Slippery Disease, Department of HEW, 1978. Subsequently re-published with additional material as The Epidemic That Never Was, Vintage Books, 1983.) A couple of years ago, I served on the Expert Committee charged with reviewing experience in coping with the SARS outbreak in Hong Kong. In recent years, the Institute of Medicine and the National Research Council have produced a number of consensus studies and hosted a variety of workshops that bear on the subjects of microbial threats, bioterrorism, and public health. For your convenience, I have listed a number of these reports in an attachment to this testimony. Their findings, conclusions, and recommendations cover many areas that I hope will prove useful in your deliberations.

The main message in my testimony today is the value of a comprehensive preparedness strategy that simultaneously protects the American people against microbial threats that are natural, accidental, or deliberate in origin. Experts in terrorism refer to dual-use technologies, meaning ones that can be used for legitimate scientific research and commerce, or turned to the nefarious purposes of terrorism. When it comes to bioterrorism, the soundest national response is a dual-purpose defense that would deter, detect, and respond effectively to microbial threats from either natural or intentional sources.

In briefly elaborating on the case for a comprehensive, dual purpose strategy to protect against both naturally occurring and deliberately inflicted microbial threats, I will touch upon five points:

1. We can expect and should prepare for continuing changes in the appearance, severity and incidence of microbial threats.

2. Our vulnerability to microbial threats has been exacerbated by the rise in drug-resistant organisms, the decline in the number of vaccine manufacturers, and a shortage of new antimicrobials.

3. Many of the same means of prevention, detection, response, and management apply to both natural and intentional microbial threats.

4. Deficiencies and variability in the public health infrastructure across different national, state and local jurisdictions represent a particularly severe gap in our nation’s capacity to respond.

5. Microbial threats from any source that are relatively unlikely, but very severe if they occur, pose a particularly demanding challenge to decision makers.

New and Newly Emerging Microbial Threats

Species survive not because they are stronger or more intelligent, but because they are better suited to their environment. Micro-organisms have been adapting and surviving successfully for hundreds of millions of years longer than plant or animal populations on the planet. In terms of sheer number, range of habitat, and total bio-mass, micro-organisms are the most abundant and versatile species on the planet. In fact, life as we know it on earth would be impossible without the positive contributions of innumerable microbial species to plants and animals. The gut of each human adult, for example, contains about two pounds of bacteria – more than 15,000 times as many individual bacteria as there are humans on earth! These internal co-habitants aid in digestion and absorption of essential nutrients, and play an important role in the development of our immune systems. Only a tiny fraction of the world’s microbes constitute a threat to plant, animal, or human life, but some of these threats are truly fearsome.

Recent decades have witnessed the appearance of dozens of infectious diseases that were previously unrecognized or that attained new geographic reach, incidence or severity. These encompass newly resistant conditions such as some forms of bacterial pneumonia, malaria, and tuberculosis; threats such as West Nile virus that have spread across the U.S.; and new global catastrophes such as AIDS. The conditions favoring emergence of new diseases are neither transient nor aberrant; they are intrinsic to modern technology and ways of life.

Among the forces promoting new microbial threats or increasing human vulnerability:

Increasing population size and density. Population growth is most rapid in low latitude countries. Large and growing cities in tropical or subtropical developing countries are frequently surrounded by peri-urban slums that lack clean water, sanitary disposal of waste, and access to medical care. Growing populations drive the need for more food, including animal protein, and closer proximity of human and animal populations, often with both occupying the same, limited space.

More rapid and frequent travel. Almost two million people cross international borders daily. In the year 2000, an estimated 400 million international travelers entered the U.S. by land, ship, or air. Every human traveler is a potential conveyer of infectious organisms.

Increased number of vulnerable individuals. Older individuals tend to mount less vigorous immune responses to infection, and the aging of the population increases the proportion that is susceptible to infectious diseases. Growing numbers of immunocompromised individuals – due to HIV infection, radiation and chemotherapy treatment for cancer, or immunosuppressive therapy in conjunction with organ transplant – also contribute to a population that is more vulnerable to infections.

Growing global commerce. Trade involves living and dead animals and animal parts shipped for food, pets, research, and by-products. Mosquitoes that are competent to transmit human infections have been introduced into new geographic areas via trade (breeding, for example, in tires on ships). Food imports have been associated with outbreaks of unfamiliar infections (such as cyclospora in the United States and Canada from raspberries imported from Guatemala). Non-food imports into the U.S. in 2002 included 47,000 mammals (including 28 species of rodents), 379,000 birds, 2 million reptiles, 49 million amphibians, and 223 million fish. Most of these animals are wild caught, not screened before shipment, suffer high mortality in transit, and gain exposure to the public. Monkeypox was imported into the U.S. in a shipment of African rodents to be sold as pets in the U.S.

Mass production in agriculture. Large concentrations of genetically similar plants and animals render agriculture vulnerable to large scale outbreaks of infection. Large, high-density populations of poultry, hogs, and other animals are similarly susceptible to infectious diseases.

Widespread antimicrobial use and misuse. Antimicrobials exert selective pressure on bacteria, viruses, fungi, and protozoa, leaving resistant strains able to survive, replicate, and, in some instances, be transmitted and become more prevalent. Approximately 40% of antimicrobials in the U.S. are used in sub-therapeutic doses to promote growth in farm animals, in aquaculture and in cultivation of fruit trees. Such chronic use of low-dose antimicrobials is especially favorable to development of resistant strains. A substantial fraction of prescribed anti-microbials are unnecessary or misused. Incomplete treatment of tuberculosis facilitated emergence of multi-drug resistant strains of the infection.

Changes in land use and human habitats. Construction, agricultural projects, drainage, dam construction, and other alterations in land use can change the ecology for disease vectors and for reservoir and intermediate animal hosts. Human development breaches traditional biophysical barriers, such as rivers and mountains. Logging roads in Africa facilitate bushmeat trade, a source of human exposure to novel pathogens. Urban habitats can facilitate the spread of infections, as occurred with air conditioned buildings and legionnaire’s disease in the U.S., and with SARS and the high-rise Amoy Gardens in Hong Kong.

Many newly acquired infectious diseases in humans derive from an animal source. This includes HIV (from primates), SARS (from civet cats or other animals), avian influenza (from birds), variant Creutzfeldt-Jacob disease (from cows infected with bovine spongiform encephalopathy), and Nipah virus (from fruit bats). When the ancestor virus to HIV adapted to spread from person to person, the results were devastating. Globally, to date, 20 million persons have died of AIDS, and approximately 40 million are living with HIV infection.

The greatest natural catastrophe of the 20th Century was the influenza pandemic of 1918-1919. In the space of less than twelve months, more than a half million Americans, many young and vigorous, lost their lives to the flu, and this was at a time when the total U.S. population was around 100 million. Worldwide, the great influenza pandemic killed at least 20 million; some estimates are as much as five times higher. The specific viral culprit was later identified as a form of influenza A that probably originated in birds. Even in an average flu season, influenza accounts for an estimated 30,000 to 40,000 deaths in the U.S. Because of its ability to undergo rapid genetic change and to move across species (such as birds, pigs, and humans) the influenza virus is a formidable pathogen. The shadow of the great pandemic of 1918-1919 darkens every discussion of the threat of influenza, including the pandemic potential of avian flu.

The natural reservoir for influenza A is aquatic birds that carry and excrete the virus, but do not experience disease. The virus periodically infects other hosts, including other kinds of poultry and mammals, which may suffer disease or death from infection. A highly pathogenic form of avian influenza is now endemic in bird populations in parts of Asia where 30% of the world’s human population live and where contact with poultry is common among rural residents. Sporadic human cases have proven fatal in more than half the clinically evident cases, although the number of sub-clinical human infections is unknown. The major concern is that mutation or genetic re-assortment may produce a viral variant that is efficiently transmitted from person to person, sowing the seed for a global pandemic.

The currently prevalent form of avian flu has shown increased severity of illness in poultry, an expanded mammalian range, and excretion of highly pathogenic virus by apparently healthy ducks. One worrisome development is the appearance of clusters of human cases, suggesting the possibility of human to human transmission, as appears likely in at least one reported instance. Efforts in some areas to monitor infection in animals and to track changes are hampered by local conditions, limited capacities, and concerns about commerce and tourism.

Early vaccine trials are underway as is research on more efficient ways to produce influenza vaccine and on the potential transmissibility of avian flu variants. In addition to this current research, a concerted strategy to cope with avian flu would incorporate intensified bilateral and multi-lateral international efforts to monitor and cull infected animal populations, accumulation of larger reserves of anti-viral drugs that may reduce the severity of a disease outbreak, and detailed plans for international sharing and domestic deployment of drugs and vaccine if and when they are needed.

Drug Resistance, Vaccine Manufacturers, and New Drugs

Drug-resistant microbes are a serious public health threat. The CDC estimates that approximately two million people acquire bacterial infections in the hospital each year, more than 70 per cent of which are resistant to at least one antimicrobial commonly used to treat them. Hospital-acquired infections claim approximately 90,000 lives each year. Drug-resistant infections typically require more costly drugs and are difficult to treat, estimated to impose an economic burden of at least $5 billion annually. While the number of resistant organisms has burgeoned, the number of newly approved antibacterial agents has declined steadily over the past twenty years, dropping from 16 between 1983 and 1987 to 7 between 1998 and 2002, and to just 3 in 2003-2004. In its 2003 report on Microbial Threats, the IOM pointed out that every antibacterial drug then in clinical development belonged to an already existing class of drugs, i.e., that not one new class of drugs was then in late-stage development.

As drug resistance spreads and vaccine-preventable threats loom, the declines in vaccine manufacturers and in new antimicrobials represent a dangerous, combined trend. Vulnerability to the reduced number of vaccine production facilities was revealed in last year’s shortage of flu vaccine. Vulnerability to drug-resistant micro-organisms plays out every day in U.S. hospitals and in clinics treating infectious diseases around the globe.

Strategies to Cope with Microbial Threats

Many of the same capacities, approaches, and tools to contend with naturally occurring infections apply equally to deliberately deployed infectious agents. Scientific research to create more effective anti-viral agents applies to influenza as it does to smallpox, and inter-disciplinary collaboration can reveal novel approaches to potential drug targets on any dangerous infectious agent. More vaccine manufacturers are needed to avert the kind of shortages seen in last year’s flu season and to provide preventives against potential agents of bioterror. Incentives for investment in new vaccines and drugs can provide more effective preventives and care for a range of natural or intentional infections. Alert physicians, surveillance systems, epidemiologic investigation, and well-equipped laboratories will be necessary in identifying the cause of any new infection, from whatever source. A strategy of prevention and containment will be needed for infectious diseases, either natural or deliberate in origin, including vaccination programs; public education; appropriate use of isolation and quarantine; utilization of drugs, devices, and treatment facilities; clear and authoritative communication; professional collaboration among health care providers, public health officials, and veterinary experts; and coordination across departmental jurisdictions and among federal, state, and local health authorities, as well as international agencies.

Of course, there are differences in preparing for the possibility of bioterror and of natural biological threats in terms of the specific agents of interest, the risks and scope of research, the means of deterrence, and the salience for special populations, such as the armed forces. An important step is being taken through the implementation of a National Science Advisory Board for Biosecurity to reduce the likelihood that legitimate research will inadvertently increase the risk of bioterrorism. A human adversary can take account of preparations and attempt to exploit a perceived, remaining weakness. This is what risk managers and military planners call the N+1 problem: prepare for N contingencies, and the enemy will try to exploit one you have not yet considered. By contrast, Nature, to paraphrase Einstein, may be subtle, but is not devious. The microbial world, however, is huge, diverse, and resilient, and a microbe’s rapid generation time and multiple means of adaptation may render its lack of intent a distinction without much of a difference when it comes to the risk to human health. Microbes, in their natural course of survival and replication, may produce consequences as terrible and terrifying as any bioterrorist. Most of what needs to be done to prepare against either will serve against both.

The Public Health Infrastructure

Public health departments in communities and states across the nation are highly variable in their capacity to respond to natural or intentional outbreaks of infection. The majority of personnel working in health departments in the U.S. today are not trained in relevant public health disciplines. Information technology and health information systems are often seriously deficient. Many public health laboratories are antiquated, and only about 60% of local health departments have any laboratory capacity whatsoever. Almost all departments lack a real-time surveillance system, and many lack a basic capacity for epidemiologic investigation. Communication networks are often ineffective and fragmented, and emergency response capabilities are severely limited. While national guidelines for reform of public health law have been proposed, many state public health statutes remain outdated and internally inconsistent. These and other shortcomings, and a comprehensive set of recommendations to overcome them, are enumerated in the IOM report on The Future of the Public’s Health (2003). Systematic improvement in the nation’s public health infrastructure would go a long way toward strengthening the nation’s ability to respond to natural or intentional infection and provide many other benefits to protect the public’s health.

Low-Likelihood, High-Consequence Events

An especially challenging dilemma for decision makers is how to respond to events that are relatively unlikely, but carry severe consequences if they materialize. Such low-likelihood, high-consequence risks include infectious diseases that may be natural (such as a new SARS, or the appearance of pandemic influenza in any given year) or intentional (such as smallpox or anthrax). In such cases, preparedness and selected measures may be prudent and wise, yet cynics and armchair critics will most often be correct if they claim the preparations were for naught. That is the nature of a low-likelihood event. If the low-likelihood, high-consequence event does eventuate, the preparations will nearly always be seen in retrospect to have been less than was optimal. The prospective dilemma intensifies when preparations are expensive, intrusive, complex, and laden with risk. These conditions make policy makers politically vulnerable, even when they are making the right decision. Acknowledging this dilemma does not excuse flawed decision making; indeed, the only hope for improvement is to learn the strategic lessons from past errors of over-reaction and under-reaction. Recognizing the dilemma, however, does place a premium on establishing clear lines of authority and the necessary resources in advance. Without such authority and means, there can be no legitimate accountability.

* * * * *

If there are ways that I or my colleagues at the Institute of Medicine or the National Academies can be helpful as you proceed with your deliberations, please do not hesitate to call upon us.

* * * * *

Selected Reports from the Institute of Medicine

and the National Research Council

All reports are published by the National Academies Press. Members of Congress, Congressional staff, and other U.S. government employees may obtain complimentary copies of any report by contacting the National Academies' Office of Congressional and Public Affairs at (202) 334-1601 or ocga@nas.edu. For more information on publications by the National Academies, please visit the National Academies Press website at www.nap.edu or the homepage of the National Academies at www.nationalacademies.org.

I. INFECTIOUS DISEASES

The Threat of Pandemic Influenza: Are We Ready? Workshop Summary (2005). Stacey Knobler, Alison Mack, Adel Mahmoud, and Stanley Lemon, editors.

Public health officials and organizations around the world remain on high alert because of increasing concerns about the prospect of an influenza pandemic, which many experts believe to be inevitable. Moreover, recent problems with the availability and strain-specificity of vaccine for annual flu epidemics in some countries and the rise of pandemic strains of avian flu in disparate geographic regions have alarmed experts about the world's ability to prevent or contain a human pandemic. This workshop summary on The Threat of Pandemic Influenza: Are We Ready? addresses these urgent concerns. The report describes what steps the United States and other countries have taken thus far to prepare for the next outbreak of "killer flu." It also looks at gaps in readiness, including hospitals' inability to absorb a surge of patients and many nations' incapacity to monitor and detect flu outbreaks. The report points to the need for international agreements to share flu vaccine and antiviral stockpiles to ensure that the 88 percent of nations that cannot manufacture or stockpile these products have access to them. It chronicles the toll of the H5N1 strain of avian flu currently circulating among poultry in many parts of Asia, which now accounts for the culling of millions of birds and the death of at least 50 persons. It also compares the costs of preparations with the costs of illness and death that could arise during an outbreak.

Learning from SARS: Preparing for the Next Disease Outbreak – Workshop Summary (2004). Stacey Knobler, Adel Mahmoud, Stanley Lemon, Alison Mack, Laura Sivitz, and Katherine Oberholtzer, editors.

The emergence of severe acute respiratory syndrome (SARS) in late 2002 and 2003 challenged the global public health community to confront a novel epidemic that spread rapidly from its origins in southern China until it had reached more than 25 other countries within a matter of months. In addition to the number of patients infected with the SARS virus, the disease had profound economic and political repercussions in many of the affected regions. Recent reports of isolated new SARS cases and a fear that the disease could reemerge and spread have put public health officials on high alert for any indications of possible new outbreaks. This report examines the response to SARS by public health systems in individual countries, the biology of the SARS coronavirus and related coronaviruses in animals, the economic and political fallout of the SARS epidemic, quarantine law and other public health measures that apply to combating infectious diseases, and the role of international organizations and scientific cooperation in halting the spread of SARS. The report provides an illuminating survey of findings from the epidemic, along with an assessment of what might be needed in order to contain any future outbreaks of SARS or other emerging infections.

Microbial Threats to Health: Emergence, Detection, and Response (2003). Mark Smolinski, Margaret Hamburg, and Joshua Lederberg, editors.

Infectious diseases are a global hazard that puts every nation and every person at risk. The recent SARS outbreak is a prime example. Knowing neither geographic nor political borders, often arriving silently and lethally, microbial pathogens constitute a grave threat to the health of humans. Indeed, a majority of countries recently identified the spread of infectious disease as the greatest global problem they confront. Throughout history, humans have struggled to control both the causes and consequences of infectious diseases and we will continue to do so into the foreseeable future. Following up on a high-profile 1992 report from the Institute of Medicine, Microbial Threats to Health examines the current state of knowledge and policy pertaining to emerging and re-emerging infectious diseases from around the globe. It examines the spectrum of microbial threats, factors in disease emergence, and the ultimate capacity of the United States to meet the challenges posed by microbial threats to human health. From the impact of war or technology on disease emergence to the development of enhanced disease surveillance and vaccine strategies, Microbial Threats to Health contains valuable information for researchers, students, health care providers, policymakers, public health officials. and the interested public.

The Resistance Phenomenon in Microbes and Infectious Disease Vectors: Implications for Human Health and Strategies for Containment – Workshop Summary (2003). Stacey Knobler, Stanley Lemon, Marian Najafi, and Tom Burroughs, editors.

The emergence of new diseases such as SARS and the looming threat of bioterrorist attacks remind us of how vulnerable we can be to infectious agents. With advances in medical technologies, we have tamed many former microbial foes, yet with few new antimicrobial agents and vaccines in the pipeline and drug resistance increasing rapidly among infectious microbes, we teeter on the brink of losing the upper hand in our ongoing struggle against these foes, old and new. The Resistance Phenomenon in Microbes and Infectious Disease Vectors examines our understanding of the relationships among microbes, disease vectors, and human hosts, and explores possible new strategies for meeting the challenge of resistance.

The Emergence of Zoonotic Diseases: Understanding the Impact on Animal and Human Health – Workshop Summary (2002). Tom Burroughs, Stacey Knobler, and Joshua Lederberg, editors.

Zoonotic diseases represent one of the leading causes of illness and death from infectious disease. As defined by the World Health Organization, zoonoses are those diseases and infections that are naturally transmitted between vertebrate animals and man with or without an arthropod intermediate. Worldwide, zoonotic diseases have a negative impact on commerce, travel, and economies. In most developing countries, zoonotic diseases are among those diseases that contribute significantly to an already overly burdened public health system. In industrialized nations, zoonotic diseases are of particular concern for at-risk groups such as the elderly, children, childbearing women, and immunocompromised individuals. The Emergence of Zoonotic Diseases: Understanding the Impact on Animal and Human Health covers a range of topics, which include: an evaluation of the relative importance of zoonotic diseases against the overall backdrop of emerging infections; research findings related to the current state of our understanding of zoonotic diseases; surveillance and response strategies to detect, prevent, and mitigate the impact of zoonotic diseases on human health; and information about ongoing programs and actions being taken to identify the most important needs in this vital area.

Considerations for Viral Disease Eradication: Lessons Learned and Future Strategies – Workshop Summary (2002). Stacey Knobler, Joshua Lederberg, and Leslie Pray, editors.

Since smallpox eradication, the science of eradication has changed and with it, our definitions of what diseases it is possible to eradicate. However, eradication must not beget complacency. As has been learned from past control or eradication attempts with a variety of viral diseases from yellow fever to influenza, accidental or intentional reintroduction is a real threat—one that could strike anywhere and for which we need to be fully prepared. The criteria for assessing eradicability of polio, measles, and other viral infections have been debated extensively. With the elimination and eradication of several viral diseases on the horizon, issues surrounding the cessation of immunization activities become exceedingly important. In an effort to better understand the dynamics of disease eradication and post-immunization policies, the Institute of Medicine's Forum on Emerging Infections hosted a two-day workshop on "The Consequences of Viral Disease Eradication." This summary of the workshop explores the principles underlying the biological challenges, medical interventions, the continuing research agenda, and operational considerations for post-immunization strategies for vaccine-preventable viral diseases, and highlights important efforts that may facilitate wise decision making.

Emerging Infectious Diseases from the Global to the Local Perspective – Workshop Summary (2001). Jonathan Davis and Joshua Lederberg, editors.

In October 1999, the Institute of Medicine's Forum on Emerging Infections convened a two-day workshop entitled "International Aspects of Emerging Infections." Key representatives from the international community explored the forces that drive emerging infectious diseases to prominence. Emerging Infectious Diseases from the Global to the Local Perspective includes summaries of the presentations from this workshop and suggests an agenda for future action. The topics addressed cover a wide range of issues, including trends in the incidence of infectious diseases around the world, descriptions of the wide variety of factors that contribute to the emergence and reemergence of these diseases, efforts to coordinate surveillance activities and responses within and across borders, and the resource, research, and international needs that remain to be addressed.

Perspectives on the Department of Defense Global Emerging Infections Surveillance and Response System: A Program Review (2001). Philip S. Brachman, Heather C. O'Maonaigh, and Richard N. Miller, editors.

This report describes the capacity, quality, and effectiveness of the international and domestic facilities and programs that are a part of the Defense Department's system to monitor and address emerging infectious diseases globally. The committee concludes that the goals of the system are in U.S. military, U.S. civilian, and global public health interests and that substantial progress has been made toward achieving system goals.

Orphans and Incentives: Developing Technology to Address Emerging Infections – Workshop Summary (1997). Polly Harrison and Joshua Lederberg, editors.

Infectious diseases remain a leading cause of prolonged illness, premature mortality, and soaring health costs. In the United States in 1995, infectious diseases were the third leading cause of death, right behind heart disease and cancer. Mortality is mounting over time, owing to HIV/AIDS, pneumonia, and septicemia, with drug resistance playing an ever-increasing role in each of these disease categories. This summary from a Forum on Emerging Infections workshop focuses on product areas where returns from the market might be perceived as being too small or too complicated by other factors to compete in industrial portfolios with other demands for investment. Vaccines are quintessential examples of such products. The lessons learned fall into four areas, including what makes intersectoral collaboration a reality, the notion of a product life cycle, the implications of divergent sectoral mandates and concepts of risk, and the roles of advocacy and public education. The summary contains an examination of the Children's Vaccine Initiative and other models, an industry perspective on the emerging infections agenda, and legal and regulatory issues.

Infectious Diseases in an Age of Change: The Impact of Human Ecology and Behavior on Disease Transmission (1995). Bernard Roizman, editor.

Twenty-first century progress against infectious diseases is threatened by urbanization, population growth, war refugees, changing sexual standards, and a host of other factors that open doors to the transmission of deadly pathogens. Infectious Diseases in an Age of Change reports on major infectious diseases that are on the rise today because of changing conditions and identifies urgently needed public health measures. This volume looks at the range of factors that shape the epidemiology of infectious diseases—from government policies to economic trends to family practices. Describing clinical characteristics, transmission, and other aspects, the book addresses major infectious threats—sexually transmitted diseases, Lyme disease, human cytomegalovirus, diarrheal diseases, dengue fever, hepatitis viruses, HIV, and malaria. The authors also look at the rising threat of drug-resistant strains of tuberculosis, rapid exhaustion of the weapons to fight bacterial infections, and prospects for vaccinations and eradication of pathogens.

II. THE PUBLIC HEALTH SYSTEM

Human Resources at U.S. Ports of Entry to Protect the Public's Health – Interim Letter Report (2005). Committee on Measures to Enhance the Effectiveness of CDC Quarantine Station Expansion Plan for U.S. Ports of Entry, Institute of Medicine.

Nearly 40 newly emerging or reemerging infectious diseases have appeared and spread to multiple continents since 1970—from HIV/AIDS and SARS to West Nile virus and poliovirus. A significant vehicle for the spread of disease today is the speed and volume of international and transcontinental travel, commerce, and human migration. These trends and the risk of bioterrorism have prompted the U.S. government to expand efforts to prevent communicable diseases of public health significance from being imported into the United States. As part of this endeavor, Congress and the Bush Administration have given CDC's Division of Global Migration and Quarantine (DGMQ) a mandate to more than triple the size of its system of quarantine stations at U.S. ports of entry and to play an active, anticipatory role in nationwide biosurveillance. DGMQ has asked the IOM to examine the proposed quarantine station expansion plans and recommend how the system should evolve to meet public health needs of the 21st century. This interim letter report, Human Resources at U.S. Ports of Entry to Protect the Public's Health, is the first of two reports responding to DGMQ's request. In this report, the IOM's Committee on Measures to Enhance the Effectiveness of CDC Quarantine Station Expansion Plan for U.S. Ports of Entry offers preliminary suggestions for the priority functions of a modern quarantine station, the competencies necessary to carry out those functions, and the types of health professionals who have the requisite competencies. The committee's final report, to be released in early summer 2005, will comprehensively assess the current role of quarantine stations and articulate a vision of their future role as a public health intervention.

Vaccine Safety Research, Data Access, and Public Trust (2005). Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program, Institute of Medicine.

The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991.  It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations.  Researchers from CDC and these managed care groups have used VSD information to study whether health problems are associated with vaccinations.  A subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database. In this report, the committee that was asked to review aspects of this program recommends two new oversight groups to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible. The Centers for Disease Control and Prevention, which oversees the VSD and the data sharing program, should create a new, independent committee to review researchers' proposals to use VSD data, monitor adherence to protocols, and advise the agency and its partners on when and how to release preliminary findings based on the data, the report says. In addition, CDC should create a new subcommittee of the National Vaccine Advisory Committee (NVAC), or tap an existing one, to enable stakeholders to review and provide input on the VSD research plan every year. The committee makes additional recommendations on specific aspects of the VSD data sharing program and on conditions governing whether, when, and how preliminary findings should be shared with others.

The Smallpox Vaccination Program: Public Health in an Age of Terrorism (2005). Alina Baciu, Andrea Pernack Anason, Kathleen Stratton, and Brian Strom, editors.

This report constitutes an archival compendium of the committee’s smallpox reports to the Centers for Disease Control and Prevention, summarizing milestones in the smallpox vaccination program and the committee’s assessment of what has been accomplished in the course of the program. The report discusses lessons learned from the vaccination program, concluding that there is a need to balance scientific communication with national security imperatives in the context of bioterrorism and similar programs in a way that preserves the authoritative voice of the CDC (or other appropriate agency, depending on the type of emergency). The report also recommends that smallpox preparedness should be defined, preparedness goals should be set based on the best available scientific and public health reasoning, preparedness should be comprehensively assessed, and the status of preparedness efforts should be communicated to the public.

"Discovery of Antivirals Against Smallpox" (2004). Stephen Harrison, et al. Proceedings of the National Academy of Sciences vol. 101, no. 31, pp. 11178-11192.

This PNAS article summarizes the findings and recommendations from a workshop hosted by the National Academies on scientific priorities in smallpox research and policies that are needed for promoting the development of effective countermeasures against any possible reintroduction of smallpox into the public community.

The Future of the Public's Health in the 21st Century (2003). Committee on Assuring the Health of the Public in the 21st Century, Institute of Medicine.

The anthrax incidents following the 9/11 terrorist attacks put the spotlight on the nation's public health agencies, placing them under an unprecedented scrutiny that added new dimensions to the complex issues considered in this report. The Future of the Public s Health in the 21st Century reaffirms the vision of Healthy People 2010 and outlines a systems approach to assuring the nation's health in practice, research, and policy. This approach focuses on joining the unique resources and perspectives of different sectors and challenges these groups to work in a concerted, strategic way to promote and protect the public's health. Focusing on diverse partnerships as the framework for public health, the book discusses (i.) the need for a shift from an individual to a population-based approach in practice, research, policy, and community engagement; (ii.) the status of the governmental public health infrastructure and what needs to be improved, including its interface with the health care delivery system; and (iii.) the roles that non-government actors, such as academia, business, local communities and the media, can play in creating a healthy nation.

Who Will Keep the Public Healthy? Educating Public Health Professionals for the 21st Century (2003). Kristine Gebbie, Linda Rosenstock, and Lyla M. Hernandez, editors.

Bioterrorism, drug-resistant disease, transmission of disease by global travel—there is no shortage of challenges facing America's public health officials. Men and women preparing to enter this field require state-of-the-art training to meet these increasing threats to the public health. But are the programs they rely on provide the high caliber professional training they require? Who Will Keep the Public Healthy? provides an overview of the past, present, and future of public health education, assessing its readiness to provide the training and education needed to prepare men and women to face 21st-century challenges. Advocating an ecological approach to public health, the Institute of Medicine examines the role of public health schools and degree-granting programs, medical schools, nursing schools, and government agencies, as well as other institutions that foster public health education and leadership. Specific recommendations address the content of public health education, qualifications for faculty, availability of supervised practice, opportunities for cross-disciplinary research and education, cooperation with government agencies, and government funding for education. Eight areas of critical importance to public health education in the 21st century are examined in depth: informatics, genomics, communication, cultural competence, community-based participatory research, global health, policy and law, and public health ethics. The report also includes a discussion of the policy implications of its ecological framework.

Financing Vaccines in the 21st Century: Assuring Access and Availability (2003). Committee on the Evaluation of Vaccine Purchase Financing in the United States, Institute of Medicine.

The national immunization system has achieved high levels of immunization, particularly for children. However, this system faces difficult challenges for the future. Significant disparities remain in assuring access to recommended vaccines across geographic and demographic populations. These disparities result in part from fragmented public-private financing in which a large number of children and adults face limited access to immunization services. Access for adults lags well behind that of children, and rates of immunizations for those who are especially vulnerable because of chronic health conditions, such as diabetes or heart and lung disease, remain low. Financing Vaccines in the 21st Century: Assuring Access and Availability addresses these challenges by proposing new strategies for assuring access to vaccines and sustaining the supply of current and future vaccines. The report recommends changes to the Advisory Committee on Immunization Practices (ACIP)—the entity that currently recommends vaccines—and calls for a series of public meetings, a post-implementation evaluation study, and development of a research agenda to facilitate implementation of the plan.

Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military (2002). Stanley Lemon, Susan Thaul, Salem Fisseha, and Heather O'Maonaigh, editors.

Infectious diseases continue to pose a substantial threat to the operational capacity of military forces. Protecting Our Forces reviews the process by which the U.S. military acquires vaccines to protect its warfighters from natural infectious disease threats. The committee found that poorly aligned acquisition processes and an inadequate commitment of financial resources within the Department of Defense vaccine acquisition process rather than uncleared scientific or technological hurdles contribute to the unavailability of some vaccines that could protect military personnel and, implicitly, the welfare and security of the nation. Protecting Our Forces outlines ways in which DoD might strengthen its acquisition process and improve vaccine availability. Recommendations, which include combining all DoD vaccine acquisition responsibilities under a single DoD authority, cover four broad aspects of the acquisition process: (i.) organization, authority, and responsibility; (ii.) program and budget; (iii.)manufacturing; and (iv.) the regulatory status of special-use vaccines.

The Anthrax Vaccine: Is It Safe? Does It Work? (2002). Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, editors.

The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA. The Anthrax Vaccine: Is It Safe? Does It Work? reports the study's conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The report also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program (2002). Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program, Institute of Medicine.

In 1998, the Department of Defense (DoD) began a program of mandatory immunization against anthrax for all military personnel. As the program proceeded, however, some military personnel and their families raised concerns about the safety and efficacy of the anthrax vaccine. Acknowledging both the need to protect military personnel and the concerns about the anthrax vaccine, Congress directed the Centers for Disease Control and Prevention (CDC) to carry out a research program on its safety and efficacy. To assist in the development of this program, CDC requested the Institute of Medicine to convene a committee to review the completeness and appropriateness of the research program. In An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, the committee makes an overall assessment of the CDC research plan and reviews the specific studies proposed by CDC in the three areas of efficacy, safety and acceptability. The committee also notes additional research needs that became evident following the bioterrorist events of 2001 and makes recommendations about the leadership of the research program.

Vaccines for the 21st Century: A Tool for Decisionmaking (2000). Kathleen R. Stratton, Jane S. Durch, and Robert S. Lawrence, editors.

Vaccines have made it possible to eradicate the scourge of smallpox, promise to do the same for polio, and have profoundly reduced the threat posed by other diseases such as whooping cough, measles, and meningitis. What is next? There are many pathogens, autoimmune diseases, and cancers that may be promising targets for vaccine research and development. This volume provides an analytic framework and quantitative model for evaluating disease conditions that can be applied by those setting priorities for vaccine development over the coming decades. The committee describes an approach for comparing potential new vaccines based on their impact on morbidity and mortality and on the costs of both health care and vaccine development. The report examines: (i.) lessons to be learned from the polio experience; (ii.) scientific advances that set the stage for new vaccines; (iii.) factors that affect how vaccines are used in the population; and (iv.) value judgments and ethical questions raised by comparison of health needs and benefits. The committee provides a way to compare different forms of illness and set vaccine priorities without assigning a monetary value to lives, and its recommendations will be important to anyone involved in science policy and public health planning: policymakers, regulators, health care providers, vaccine manufacturers, and researchers.

Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention – Workshop Summary (2000). Jonathan Davis, editor.

This workshop summary examines how the managed care revolution has created both problems and opportunities in the fight against infectious diseases. It highlights ways in which managed care systems can aid research, develop clinical guidelines, manage the use of antibiotics, support public education efforts, and monitor the spread of emerging infections and microbial resistance.

Public Health Systems and Emerging Infections: Assessing the Capabilities of the Public and Private Sectors – Workshop Summary (2000). Jonathan Davis and Joshua Lederberg, editors.

With a focus on our knowledge and understanding of the role of private and public health sectors in emerging infectious disease surveillance and response, this workshop summary explores the effects of the privatization of public health laboratories and the modernization of public health care. The issues discussed included epidemiological investigation, surveillance, communication, coordination, resource allocations, and economic support.

Assessment of Future Scientific Needs for Live Variola Virus (1999). Committee on the Assessment of Future Scientific Needs for Variola Virus, Institute of Medicine.

In 1980, the World Health Organization (WHO) officially declared that smallpox had been eradicated. In 1986, WHO's international Ad Hoc Committee on Orthopox Virus Infections unanimously recommended destruction of the two remaining official stocks of variola virus, one at the Centers for Disease Control and Prevention and the other at the VECTOR laboratory in Siberia. In June 1999, WHO decided to delay the destruction of these stocks. Informing that decision was Assessment of Future Scientific Needs for Variola Virus, which examines (i.) whether the sequenced variola genome, vaccinia, and monkey pox virus are adequate for future research or whether the live variola virus itself is needed to assist in the development of antiviral therapies; (ii.) what further benefits, if any, would likely be gained through the use of variola in research and development efforts related to agent detection, diagnosis, prevention, and treatment; and (iii.) what unique potential benefits, if any, the study of variola would have in increasing our fundamental understanding of the biology, host-agent interactions, pathogenesis, and immune mechanisms of viral diseases.

America's Vital Interest in Global Health: Protecting Our People, Enhancing Our Economy, and Advancing Our International Interests (1997). Board on International Health, Institute of Medicine.

This report focuses on the interest of the United States in global health developments, arguing that this country has a vital and direct stake in the health of people around the globe and that this interest derives from both America's long and enduring tradition of humanitarian concern and compelling reasons of enlightened self-interest. For the United States to engage successfully in global health, coordination among the multiple U.S. agencies with statutory responsibilities in the area is needed, as well as the formation of partnerships with the U.S. industrial and academic sectors and nongovernmental organizations, other nations, and international organizations. This report stresses those areas of U.S. global health engagement that are most likely to benefit the health of the U.S. population and recommends changes in policy and implementation that can enhance the health of Americans and other peoples of the world, provide economic benefit, and advance U.S. global leadership.

III. BIOTERRORISM AND SECURITY

Biotechnology Research in an Age of Terrorism (2004). Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology, Development, Security, and Cooperation, National Research Council.

In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These experiments of concern include making an infectious agent more lethal and rendering vaccines powerless.

Seeking Security: Pathogens, Open Access, and Genome Databases (2004). Committee on Genomics Databases for Bioterrorism Threat Agents, National Research Council.

Within the last 30 years, the genomes of thousands of organisms, from viruses, to bacteria, to humans, have been sequenced or partially sequenced and deposited in databases freely accessible to scientists around the world. This information is accelerating scientists' ability to fight disease and make other medical advances, but policymakers must consider the possibility that the information could also be used for destructive purposes in acts of bioterrorism or war. Based in part on views from working biological scientists, the report concludes that current policies that allow scientists and the public unrestricted access to genome data on microbial pathogens should not be changed. Because access improves our ability to fight both bioterrorism and naturally occurring infectious diseases, security against bioterrorism is better served by policies that facilitate, not limit, the free flow of this information.

Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents (2004). Lois M. Joellenbeck, Jane S. Durch, and Leslie Z. Benet, editors.

In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. According to this Congressionally mandated report from the National Academies, to successfully develop these drugs, vaccines, and other medical interventions against biowarfare agents, Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense. The report recommends that Congress should improve liability protections for those who develop and manufacture these products in order to stimulate willingness to invest in new research and development for biowarfare protection. Giving Full Measure to Countermeasures also identifies other challenges such as the need for appropriate animal models and laboratories equipped with high-level biosafety protections that will require attention if DoD efforts to develop new medical countermeasures are to be successful.

Biological Threats and Terrorism: Assessing the Science and Response Capabilities –Workshop Summary (2002). Stacey Knobler, Adel Mahmoud, and Leslie Pray, editors.

In the wake of the September 11th and anthrax events, our nation s bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. In a three-day workshop, convened by the Institute of Medicine's Forum on Emerging Infections, experts from each of these communities came together to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities. From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework in order to attract the attention of Congress and the public in order to garner sufficient and sustainable support for such initiatives. No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be prioritized and addressed in order to assure a rapid and effective response to another bioterrorist attack.

Countering Agricultural Bioterrorism (2002). Committee on Biological Threats to Agricultural Plants and Animals, National Research Council.

Public confidence in the security of the US food and fiber system has been sustained by the quality, variety, abundance, and affordability of agricultural products in the United States. Although the system in place to defend against unintentional threats to agriculture has weaknesses and needs, the demonstrated ability of the system to resolve, accommodate, or manage critical food safety problems, temporary shortages of some commodities, plant and animal infestations and diseases, and natural disasters indicates that, in general, such confidence has been warranted. However, over the last several years, there has been recognition of the possibility and consequences of intentional threats directed at US agriculture. Such attacks could come from foreign or domestic terrorists and use biological, chemical, or radiological agents. They could be directed at the pre-harvest (live plant and live animal) or post-harvest (processing and distribution) stages of food and fiber production. Countering Agricultural Bioterrorism assesses the vulnerability of US agriculture to intentional threats and provides recommendations needed to strengthen and adapt the US system for defense against biological threats to agriculture.

Making the Nation Safer: The Role of Science and Technology in Countering Terrorism (2002). Committee on Science and Technology for Countering Terrorism, National Research Council.

Vulnerabilities abound in U.S. society. The openness and efficiency of our key infrastructures transportation, information and telecommunications systems, health systems, the electric power grid, emergency response units, food and water supplies, and others make them susceptible to terrorist attacks. Making the Nation Safer discusses technical approaches to mitigating these vulnerabilities. A broad range of topics are covered in this report, including: (i.) nuclear and radiological threats, such as improvised nuclear devices and dirty bombs; (ii.) bioterrorism, medical research, agricultural systems and public health; (iii.) toxic chemicals and explosive materials; (iv.) information technology, such as communications systems, data management, cyber attacks, and identification and authentication systems; (v.) energy systems, such as the electrical power grid and oil and natural gas systems; (vi.) transportation systems; (vii.) cities and fixed infrastructures, such as buildings, emergency operations centers, and tunnels; (viii.) the response of people to terrorism, such as how quality of life and morale of the population can be a target of terrorists and how people respond to terrorist attacks; and (ix.) linked infrastructures, i.e. the vulnerabilities that result from the interdependencies of key systems. In each of these areas, there are recommendations on how to immediately apply existing knowledge and technology to make the nation safer and on starting research and development programs that could produce innovations that will strengthen key systems and protect us against future threats. The report also discusses issues affecting the government s ability to carry out the necessary science and engineering programs and the important role of industry, universities, and states, counties, and cities in homeland security efforts. A long-term commitment to homeland security is necessary to make the nation safer, and this book lays out a roadmap of how science and engineering can assist in countering terrorism.

Countering Bioterrorism: The Role of Science and Technology (2002). Committee on Science and Technology for Countering Terrorism, National Research Council.

This publication reprints material from the above report, Making the Nation Safer: The Role of Science and Technology in Countering Terrorism (2002), that dealt specifically with issues relating to bioterrorism.

Preparing for Terrorism: Tools for Evaluating the Metropolitan Medical Response System Program (2002). Frederick J. Manning and Lewis Goldfrank, editors.

The Metropolitan Medical Response System (MMRS) program of the U. S. Department of Health and Human Services (DHHS) provides funds to major U. S. cities to help them develop plans for coping with the health and medical consequences of a terrorist attack with chemical, biological, or radiological (CBR) agents. DHHS asked the Institute of Medicine to assist in assessing the effectiveness of the MMRS program by developing appropriate evaluation methods, tools, and processes to assess both its own management of the program and local preparedness in the cities that have participated in the program. This report provides the managers of the MMRS program and others concerned about local capabilities to cope with CBR terrorism with three evaluation tools and a three-part assessment method.

Chemical and Biological Terrorism: Research and Development to Improve Civilian Medical Response (1999). Committee on R&D Needs for Improving Civilian Medical Response to Chemical and Biological Terrorism Incidents, Institute of Medicine.

What do we need to know to help emergency and medical personnel prepare for terrorist attacks? Chemical and Biological Terrorism identifies the R&D efforts needed to implement recommendations in key areas: pre-incident intelligence, detection and identification of chemical and biological agents, protective clothing and equipment, early recognition that a population has been covertly exposed to a pathogen, mass casualty decontamination and triage, use of vaccines and pharmaceuticals, and the psychological effects of terror. Specific objectives for computer software development are also identified. The report addresses the differences between a biological and chemical attack, the distinct challenges to the military and civilian medical communities, and other broader issues.

Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation, A Report to the Cooperative Threat Reduction Program of the U.S. Department of Defense (1997). U.S.-Russian Collaborative Program for Research and Monitoring of Pathogens of Global Importance Committee, National Research Council.

After extensive consultations with key Russian officials and scientific leaders, and drawing on the experience gained through the initiation of six pilot projects at two Russian facilities to investigate the practical aspects of cooperation, the National Academy of Sciences Committee on U.S.-Russian Cooperation on Dangerous Pathogens has recommended a five-year Pathogens Initiative, followed by a second phase of sustained joint U.S.-Russian research and related efforts. The program would support collaboration on the epidemiology, prevention, diagnosis, and therapy of diseases associated with dangerous pathogens that pose serious public health threats, as well as related fundamental research. The Pathogens Initiative would engage a substantial number of highly qualified specialists from the former Soviet biological weapons complex and would serve important U.S. national security and public health goals.

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